Powder for oral Azimed suspension is shown for treatment of the infections caused by the microorganisms sensitive to azithromycin:

• ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, average otitis);
• respiratory infection (bacterial bronchitis, community-acquired pneumonia);
• an infection of leather and soft tissues the migrating erythema (initial stage of a disease of Lyme), an ugly face, impetigo, secondary pyodermatoses;
• an infection which are transferred sexually: the simple genital infections caused by Chlamydia trachomatis.

Structure

Active ingredient: azithromycin;

5 ml of suspension dihydrate azithromycin in terms of azithromycin;

Excipients: sucrose, sodium phosphate, hydroxypropyl cellulose, xanthane gum, silicon dioxide colloidal waterless, fragrance cherry, fragrance banana, fragrance vanilla.

Contraindication

Hypersensitivity to active ingredient, other components of medicine or to other makrolidny antibiotics. In view of a theoretical possibility of an ergotism azithromycin should not be applied along with ergot derivatives.

to children with body weight to 15 kg.

Route of administration and doses

to Use medicament in the form of a single daily dose at least in 1 hour prior to or in 2 hours after a meal. To measure a dose by means of the oral dosing of the syringe or a spoon enclosed in packing.

Directly after use of suspension to the child needs to allow to drink several drinks of liquid to wash away and swallow residues of suspension in an oral cavity.

in case of the admission of reception of 1 dose of medicine should accept the passed dose as soon as possible, and the subsequent – at an interval of the 24th hour.

In infections of ENT organs and airways, skin and soft tissues (except the chronic migrating erythema) the general dose of azithromycin makes 30 mg/kg of body weight (10 mg/kg of body weight of 1 times a day). Duration of treatment is 3 days.

Feature of application

Pregnant

during pregnancy only according to vital indications.

Children

to Apply to children with body weight more than 15 kg. To children with body weight less than 15 kg are recommended to appoint Azimed®, 100 mg / 5 ml.

Drivers

Proof that azithromycin can worsen ability to steer motor transport or to work with other mechanisms, no, but it is necessary to consider a possibility of development of side reactions, such as dizziness, drowsiness, disorders of vision.

Overdose

Experience of clinical use of azithromycin demonstrates to what side effects which develop at reception high than is recommended, medicine doses, are similar that are observed at application of usual therapeutic doses. They can include diarrhea, nausea, vomiting, a reverse hearing loss. In case of overdose if necessary intake of activated carbon and performing the general symptomatic and supporting treatment is recommended.

Side effects

• from blood and lymphatic system: infrequently – a leukopenia, a neutropenia, an eosinophilia; it is unknown – thrombocytopenia, hemolytic anemia;
• from mentality: infrequently – nervousness, insomnia; seldom – agitation; it is unknown – aggression, concern, the increased psychomotor activity, a delirium, hallucinations;
• from nervous system: often – a headache; infrequently – dizziness, drowsiness, paresthesia, a dysgeusia; it is unknown - a faint, spasms, an anosmia, a parosmiya, an ageusia, a myasthenia gravis, a hypesthesia;
• from organs of sight: often – visual frustration;
• from organs of hearing: infrequently – a hearing disorder, vertigo; it is unknown – deterioration in hearing, including deafness and/or a ring in ears;
• from heart: infrequently – palpitation; it is unknown – torsade de pointes (torsade de pointes), arrhythmia, including ventricular tachycardia (it was revealed that they are also called by other makrolidny antibiotics), lengthening of an interval of QT on the ECG;
• from vessels: infrequently – inflows; it is unknown – arterial hypotension;
• from a respiratory system: infrequently – dispnoe, nasal bleeding, breath dysfunctions, rhinitis;
• from a digestive tract: very often – diarrhea; often – nausea, vomiting, discomfort in a stomach (pains/spasms); infrequently – gastritis, a meteorism, dyspepsia, a dysphagy, dryness in a mouth, an eructation, ulcers in an oral cavity, saliva hypersecretion, anorexia, a lock; it is unknown - discoloration of language, pancreatitis;

Interaction

with care azithromycin along with other medicines which can extend QT interval.

Antacids. At simultaneous application of antacids in general changes in bioavailability of medicine are not observed though plasma peak concentration of azithromycin decrease by 30%. Azithromycin needs to be accepted at least in 1 hour prior to or in the 2nd hour after reception of an antacid.

Tsetirizin. At healthy volunteers at simultaneous use of azithromycin within 5 days from tsetiriziny 20 mg in an equilibrium state the phenomena of pharmacokinetic interaction or significant changes of an interval of QT were not observed.

Didanozin. At simultaneous application of daily doses in 1200 mg of azithromycin with didanoziny influence on pharmacokinetics of a didanozin in comparison with placebo was not revealed.

Digoksin. It was reported that simultaneous application of makrolidny antibiotics, including azithromycin and substrates of the R-glycoprotein, such as digoxin, leads to increase in level of substrate of the R-glycoprotein in blood serum. Therefore, at simultaneous use of azithromycin and digoxin it is necessary to consider a possibility of increase in concentration of digoxin in blood serum.

Zidovudin. Single doses of 1000 mg and 1200 mg or repeated doses of 600 mg of azithromycin did not influence plasma pharmacokinetics or discharge with urine of a zidovudine or its glucuronic metabolites. However intake of azithromycin increased concentration of a fosforilirovanny zidovudine, clinically active metabolite, in mononukleara in peripheric circulation. The clinical importance of these data is not clear, but can be useful to patients.

Ergot. Considering theoretical possibility of an ergotism, simultaneous introduction of azithromycin with derivatives of an ergot is not recommended.

Azithromycin has no significant interaction with the hepatic system of P450 cytochrome. It is considered that medicine has no pharmacokinetic medicinal interaction which is observed with erythromycin and other macroleads. Azithromycin does not cause induction or an inactivation of P450 cytochrome through cytochrome-metabolitny a complex.

conducted pharmacokinetic researches of use of azithromycin and the following medicines which metabolism substantially happens to P450 cytochrome participation.

Atorvastatin. Simultaneous application of an atorvastatin (10 mg a day) and azithromycin (500 mg a day) did not cause change of concentration of an atorvastatin in blood plasma (on the basis of the analysis of inhibition of GMG-KoA-reduktazy).

Karbamazepin. In a research of pharmacokinetic interaction at healthy volunteers azithromycin did not show considerable influence on plasma levels of carbamazepine or on its active metabolites.

Cimetidinum. In a pharmacokinetic research of influence of the single dose of Cimetidinum on pharmacokinetics of azithromycin accepted in 2 hours prior to intake of azithromycin, no changes of pharmacokinetics of azithromycin were observed.

to Store

in original packing at a temperature not above 25 °C.

Prepared suspension to store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Expiration date - 2 years.

Expiration date of ready suspension - 10 days.